A Phase 1 Study of Sapanisertib (TAK-228) in East Asian Patients with Advanced Nonhematological Malignancies.

ABSTRACT:

Background

Sapanisertib is an oral, highly selective inhibitor of mammalian target of rapamycin complexes 1 and 2.

Objective

The aim of this study was to assess the safety, tolerability, pharmacokinetics, preliminary efficacy, and to establish the recommended phase 2 dose (RP2D) of sapanisertib.

Patients and methods

In this dose-escalation and expansion study, East Asian patients with nonhematologic malignancies received increasing sapanisertib doses once-daily (QD; starting at 2 mg) or once-weekly (QW; starting at 20 mg) in 28-day cycles.

Results

Among 28 patients (QD dosing, n = 22; QW dosing, n = 6), three dose-limiting toxicities were reported (stomatitis [n = 2], gastrointestinal inflammation, gingivitis, and acute myocardial infarction [all n = 1]), all i

SUBMITTER: Shimizu T 

PROVIDER: S-EPMC8994735 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature